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Pipeline

Samsung Bioepis is advancing an extensive pipeline of biosimilar candidates through process innovation and an unwavering commitment to quality.

Since its establishment in February 2012, Samsung Bioepis has been committed to increasing patient access to high-quality medicines through the development of biosimilars. From cell line generation through clinical development, Samsung Bioepis has implemented high quality standards at every step. This means Samsung Bioepis employs the latest analytical techniques for physicochemical and functional analyses, while using comprehensive control strategies and real-time monitoring to ensure consistency throughout the manufacturing process. By doing so, Samsung Bioepis is able to develop biosimilars that target a broad spectrum of diseases. Biogen and Merck, which is known as MSD outside of the United States and Canada, are responsible for commercializing Samsung Bioepis’ products in designated territories worldwide following approval.

Samsung Bioepis is advancing an extensive pipeline of biosimilar candidates that cover unmet patient need. The initial six biosimilar candidates are focused on immunology, oncology and metabolic diseases.

Samsung Bioepis Pipeline
Project Code INN Reference Biologic Status
SB4biosimilar candidate Etanercept Enbrel®
  • Approved by MFDS (Korea) in Sep 2015
  • Approved by EC (Europe) in Jan 2016
  • Approved by TGA (Australia) in Jul 2016
  • Approved by HC (Canada) in Aug 2016
  • Approved by ANVISA (Brazil) in Dec 2017
SB2biosimilar candidate Infliximab Remicade®
  • Approved by MFDS (Korea) in Dec 2015
  • Approved by EC (Europe) in May 2016
  • Approved by TGA (Australia) in Nov 2016
  • Approved by FDA (US) in Apr 2017
  • Approved by HC (Canada) in Dec 2017
SB5biosimilar candidate Adalimumab Humira®
  • Approved by EC (Europe) in Aug 2017
  • Approved by MFDS (Korea) in Sep 2017
  • Approved by TGA (Australia) in Jan 2018
SB9biosimilar candidate Insulin Glargine Lantus®
  • Approved by EC (Europe) in Jan 2017
  • Tentatively approved by FDA (US) in Jul 2017
SB3biosimilar candidate Trastuzumab Herceptin®
  • Approved by EC(Europe) in Nov 2017
  • Approved by MFDS (Korea) in Nov 2017
  • Filing accepted by FDA (US) in Dec 2017
SB8biosimilar candidate Bevacizumab Avastin®
  • Undergoing Phase III clinical trials
  • * As of December 2017
  • * SB9 is being developed by Merck, which is known as MSD outside of the United States and Canada, with partial funding by Samsung Bioepis.